Pharmaceutical References

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New and Bestselling

Pharmaceutical References from CRC Press

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Contents Drug Development ..............................................4 Drug Delivery ....................................................10 Drug Discovery ..................................................12 Regulation Standards..........................................14 Page 5

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Manufacturing & Engineering ............................15 Pharmacology & Toxicology ..............................20

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Key Contacts

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Barbara Norwitz Executive Editor, Medical Barbara.Norwitz@taylorandfrancis.com Direct: 561-998-2587

Your Medical Marketing Team

To view more information and complete tables of contents for these and many other related books, Visit us at

www.crcpress.com

e-mail: orders@crcpress.com 1-800-634-7064 • 1-561-994-0555 +44 (0) 1235 400 524 GMM07 MC_ISSUU 7.10.13gtr

Nally Dookwah-Abrams Marketing Manager for USA & Canada Email: Nally.Dookwah-Abrams@taylorandfrancis.com Direct: 561-361-6026 Matt De Bono Senior Marketing Manager for the UK, Europe, Rest of World Markets Email: matt.debono@tandf.co.uk Direct: +44 (20) 755 19391 Dominique McCann Marketing Executive for the UK, Europe, Rest of World Markets Email: dominique.mccann@tandf.co.uk Direct: +44 (20) 701 75895

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CRC Press

Taylor & Francis Group

Dear Practitioner: CRC Press is a global publisher of premier books in pharmaceutical science and related fields. In this catalog, we are pleased to present a comprehensive collection of our new and bestselling titles written by experts from around the world. Many of these traditional format books are also available digitally, so you can choose the option that best meets your needs.

Do you have an idea for a book in pharmaceutical science? We welcome proposals for new book concepts. Please contact Executive Editor Barbara Norwitz at Barbara.Norwitz@taylorandfrancis.com to discuss your project.

We look forward to providing you with superior references to help you meet the desired goals of your practice in 2013 and beyond.

Sincerely,

CRC Press Marketing Team, Medical

www.crcpress.com • 1-800-634-7064 • 1-561-994-0555 • +44 (0) 1235 400 524

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Drug Development Forthcoming!

New!

Generic Drug Product Development

Making and Using Antibodies

Solid Oral Dosage Forms, Second Edition

A Practical Handbook, Second Edition

Edited by

Edited by

Leon Shargel

Gary C. Howard

Applied Biopharmaceutics, Raleigh, North Carolina, USA

The Gladstone Institutes, San Francisco, California, USA

Isadore Kanfer

Matthew R. Kaser

Rhodes University, Grahamstown, South Africa

Generic Drug Product Development: Solid Oral Dosage Forms presents in-depth discussions from more than 30 noted specialists on topics such as quality control, experimental formulations, pharmaceutical ingredients, conventional and modified-release products, and bioequivalence. It considers key elements in the formulation of generic drug products— including the availability of raw materials and chemical purity.

The book outlines a variety of legal, regulatory, and patent challenges presented by the brand-name pharmaceutical industry. It describes scale up, postapproval changes, and post-marketing surveillance and details the ANDA regulatory process. This second edition contains new chapters on experimental formulation development and the relationship between the FDA and the United States Pharmacopeia.

Selected Contents: Introduction Active Pharmaceutical Ingredient Analytical Methods Development and Methods Validation for Solid Oral Dosage Forms Experimental Formulation Development: Immediate Release Dosage Forms Experimental Formulation Development: Controlled/Modified Release Dosage Forms Scale-up, technology transfer and process performance qualification Drug Stability Quality Control and Quality Assurance Drug Product Performance, In Vitro ANDA Regulatory Approval Process Bioequivalence and Drug Product Assessment, In Vivo Statistical Considerations for Establishing Bioequivalence Outsourcing Bioavailability and Bioequivalence Studies to Contract Research Organizations Post-Approval Changes and Post-Marketing Reporting of Adverse Drug Experiences...

Catalog no. H8635, October 2013, c. 416 pp.

ISBN: 978-1-4200-8635-5, $199.95 / £125.00 Also available as an eBook

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Bell & Associates, San Francisco, California, USA

Antibodies protect us from a wide range of infectious diseases and cancers and have become an indispensable tool in science—both for conventional immune response research as well as other areas related to protein identification analysis. This second edition of Making and Using Antibodies: A Practical Handbook provides clear guidance on all aspects of how to make and use antibodies for research along with their commercial and industrial applications.

Keeping pace with new developments in this area, all chapters in this new edition have been revised, updated, or expanded. Along with discussions of current applications, new material in the book includes chapters on western blotting, aptamers, antibodies as therapeutics, quantitative production, and humanization of antibodies. The authors present clear descriptions of basic methods for making and using antibodies and supply detailed descriptions of basic laboratory techniques. Each chapter begins with introductory material, allowing for a better understanding of each concept, and practical examples are included to help readers grasp the real-world scenarios in which antibodies play a part.

From the eradication of smallpox to combating cancer, antibodies present an attractive solution to a range of biomedical problems. They are relatively easy to make and use, have great flexibility in applications, and are cost effective for most labs. This volume will assist biomedical researchers and students and pave the way for future discovery of new methods for making and using antibodies for a host of applications.

Selected Contents: Antibodies. Antigens and Adjuvants. Production of Polyclonal Antibodies. Purification and Characterization of Antibodies. Production of Monoclonal Antibodies. Quantitative Production of Monoclonal Antibodies. Making Antibodies in Bacteria. Selection of Aptamers. Chemical and Proteolytic Modification of Antibodies. Western Blots and Other Applications. Immunohistochemical Methods. Immunoelectron Microscopy. Flow Cytometry. ELISAs. Humanization of Antibodies. ...

Catalog no. K13167, July 2013, 458 pp., Soft Cover ISBN: 978-1-4398-6908-6, $149.95 / £95.00 Also available as an eBook

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Drug Development Pharmaceutical Formulation Development of Peptides and Proteins

Drug Stereochemistry Analytical Methods and Pharmacology, Third Edition

Second Edition

Edited by

Edited by

Krzysztof Jozwiak, W. J. Lough, and Irving W. Wainer

Lars Hovgaard

Novo Nordisk A/S, Malov, Denmark

Sven Frokjaer and Marco van de Weert University of Copenhagen, Denmark

The rapid advances in recombinant DNA technology and the increasing availability of peptides and proteins with therapeutic potential are a challenge for pharmaceutical scientists who have to formulate these compounds as drug products.

Pharmaceutical Formulation Development of Peptides and Proteins, Second Edition discusses the development of therapeutic peptides and proteins, from the production of active compounds via basic pre-formulation and formulation to the registration of the final product. Providing integrated solutions, this book discusses: • The synthesis of peptides and the biotechnological production of proteins through recombinant DNA technology • The physicochemical characteristics and stability of peptides and proteins • The formulation of proteins as suspensions, solutions, and (mostly freeze-dried) solids • The opportunities and challenges of nonparenteral delivery of peptides and proteins • Risk factors, specifically the development of an unwanted immune response • A simulation approach to describe the fate of peptides and proteins upon administration to a biological system • The documentation required to register a protein-based drug

This third edition has been updated to cover all aspects of chiral drugs from the academic, governmental, industrial, and clinical perspectives. New topics include the use of enzymes in the synthesis and resolution of enantiometrically pure compounds in drug discovery; how stereochemistry impacts decisions made in the absorption, distribution, metabolism, excretion, and toxicity (ADMET) stages of drug discovery; and issues faced during the final stages of the drug development process. It also discusses the impact of International Conference on Harmonisation (ICH) on the use of single isomer drugs, chiral switches, molecular chiral recognition, and legal perspectives.

Catalog no. H9238, November 2012, 332 pp.

ISBN: 978-1-4200-9238-7, $239.95 / £150.00 Also available as an eBook

Pharmacogenomics of Alcohol and Drugs of Abuse Edited by

Amitava Dasgupta University of Texas, Houston, USA

Loralie J. Langman Mayo Clinic, Rochester, Minnesota, USA

Peptide Synthesis Protein Expression Protein Purification Characterization of Therapeutic Peptides and Proteins Chemical Pathways of Peptide and Protein Degradation Physical Instability of Peptides and Proteins Peptide and Protein Derivatives Peptides and Proteins as Parenteral Solutions Peptides and Proteins as Parenteral Suspensions Rational Design of Solid Protein Formulations ...

Pharmacogenomics is the basis of personalized medicine, which is said to be the medicine of the future.

Understanding genetic variation in alcohol response is vital for professionals involved in alcohol rehabilitation programs. This volume focuses on how pharmacogenomic principles are applied to alcohol and drug testing and treatment and discusses the role of the clinical laboratory in the practice of personalized medicine. With contributions from a range of experts, the text presents the genetic aspects of alcohol metabolism and drugs of abuse, including marijuana, cocaine, and amphetamine. It also covers methodologies in pharmacogenomic testing.

Catalog no. K12494, November 2012, 392 pp.

ISBN: 978-1-4398-5388-7, $159.95 / £99.00 Also available as an eBook

Catalog no. K12633, April 2012, 252 pp.

ISBN: 978-1-4398-5611-6, $149.95 / £95.00 Also available as an eBook

Selected Contents:

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Drug Development Safety Pharmacology in Pharmaceutical Development Approval and Post Marketing Surveillance, Second Edition

Pharmaceutical Stress Testing Predicting Drug Degradation, Second Edition Edited by

Steven W. Baertschi, Karen M. Alsante, and Robert A. Reed

Shayne C. Gad Gad Consulting Services, Cary, North Carolina, USA

Safety pharmacology is the evaluation and study of the pharmacological effects of a potential drug that are unrelated to the desired therapeutic effect. These effects often present a hazard—particularly in individuals with compromised or limited organ system functions.

Safety Pharmacology in Pharmaceutical Development: Approval and Post Marketing Surveillance, Second Edition covers safety pharmacology from the regulatory requirements down to the studies that must be done to justify them. Using the author’s more than 30 years of direct experience, the book incorporates tricks and practical insights for making studies work and understanding why they fail.

The second edition includes current regulations, including USFDA and those from Europe and Japan.

Presenting a clear description of what is needed and why for supporting drug development, the book focuses on updated test methods, interpretation, and science. It covers the core and supplemental batteries of test procedures and how to do them and provides an overview of available facilities and contract organizations for performing studies.

Selected Contents: Safety Pharmacology: Background, History, Issues, And Concerns Regulatory Requirements: ICH, FDA, EMA, And Japan

“The authors and editor have done a superb job of combining the theoretical, chemical, and practical aspects of stress testing … the text is a 'must have' for those involved in stability testing.”

—Drug Development and Industrial Pharmacy

“This excellent reference on pharmaceutical stress testing will serve its purpose well, especially for pharmaceutical product development scientists and for members of regulatory agencies who are actively involved in the drug review and approval process.”

—Doody's Review Service

Catalog no. H100006, July 2011, 624 pp.

ISBN: 978-1-4398-0179-6, $259.95 / £165.00 Also available as an eBook

Generic Drug Product Development Specialty Dosage Forms Leon Shargel Applied Biopharmaceutics, Raleigh, North Carolina, USA

Isadore Kanfer Rhodes University, Grahamstown, South Africa

The Immune System

This volume explores the issues related to providing evidence of pharmaceutical equivalence and bioequivalence for specialty drug products. It describes various scientific approaches and regulatory requirements for manufacturers who need to demonstrate the therapeutic equivalence of generic specialty drug products to brand name alternatives. The book discusses measurement of drug product quality and performance, as well as the regulatory and scientific requirements of topical, nasal and inhalation, and transdermal drug delivery products, along with generic biologics and modified release parenteral drug products.

Catalog no. K12039, April 2012, 213 pp.

ISBN: 978-1-4398-4567-7, $149.95 / £95.00 Also available as an eBook

Catalog no. DK7786, March 2010, 288 pp.

ISBN: 978-0-8493-7786-0, $219.95 / £135.00 Also available as an eBook

Regulatory Requirements Principles of Screening and Study Design Cardiovascular System Central Nervous System Respiratory System Renal Function The Gastrointestinal System

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Drug Development Active Pharmaceutical Ingredients Development, Manufacturing, and Regulation, Second Edition Edited by

Stanley Nusim S.H. Nusim & Associates, Inc., Aventura, Florida, USA

Active Pharmaceutical Ingredients is an unparalleled guide to the development, manufacturing, and regulation of the preparation and use of Active Pharmaceutical Ingredients (APIs) globally.

Topics include: • Safety, efficacy, and environmental/regulatory requirements • Analysis of the recent movement of API manufacturing from the U.S. and Europe to countries such as India and China • The FDA’s intensified foreign inspection program • Multi-use and flexible design facilities • The shift from maintenance scheduling to built-in reliability This Second Edition focuses on the quality control regulations for APIs that have been added or amended since the first edition. These updates help ensure that pharmaceutical professionals and drug manufacturers meet the established and required guidelines set forth by the United States and international regulatory agencies.

Contents: Introduction Process Development, Scaleup, and Design Technology Transfer and First Manufacture Plant Design and Construction Regulatory Requirements: U.S. Regulatory Requirements: Outside U.S. Process Validation Quality Assurance and Control Environmental Control Safety Plant Operations Bulk Sterile Manufacturing Materials Management Plant Maintenance Catalog no. H100022, December 2009, 320 pp.

ISBN: 978-1-4398-0336-3, $259.95 / £162.00 Also available as an eBook

Pharmaceutical Statistics Practical and Clinical Applications, Fifth Edition Sanford Bolton Creskill, New Jersey, USA

Charles Bon Biostudies Solutions, LLC, Wilmington, North Carolina, USA

Through the use of practical examples and solutions, this volume examines various statistical applications and research issues in the pharmaceutical industry, particularly in clinical trials and bioequivalence studies. It covers the in vitro-in vivo correlation, and how it can be used in the drug development process. It discusses adaptive designs in clinical research, advanced statistical designs, and one- and two-sided statistical tests. It also examines interim and sequential analysis for clinical trials and bioequivalence studies, discusses assumptions and applications of nonparametric methods, and expands on the concepts of multiple and logistic regression.

Catalog no. H7422, December 2009, 670 pp.

ISBN: 978-1-4200-7422-2, $259.95 / £162.00 Also available as an eBook

Approaches to the Conformational Analysis of Biopharmaceuticals Roger L. Lundblad Lundblad Biotechnology, Chapel Hill, North Carolina, USA

Conformational analysis is becoming more critical in the development of generic biopharmaceuticals. This book describes methods used to establish comparability between potentially identical products, providing researchers with a critical description of studies drawn from the current literature. The text covers physical methods, such as differential scanning calorimetry, light scanning, and analytical ultracentrifugation, as well as chemical methods, including hydrogen–deuterium exchange and trace labeling.

The author shows how these methods support comparability claims for generic biologicals and assure structural integrity of active pharmaceutical ingredients in final drug products.

Catalog no. K10401, December 2009, 366 pp.

ISBN: 978-1-4398-0780-4, $167.95 / £107.00 Also available as an eBook

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Drug Development Biodrug Delivery Systems

Preclinical Drug Development

Fundamentals, Applications and Clinical Development

Edited by

Edited by

Second Edition Mark Rogge Biogen Idec Corporation, Cambridge, Massachusetts, USA

David R. Taft

Mariko Morishita Hoshi University, Tokyo, Japan

Kinam Park Purdue University, West Lafayette, Indiana, USA

Biodrug Delivery Systems: Fundamentals, Applications and Clinical Development presents the work of an international group of leading experts in drug development and biopharmaceutical science who discuss the latest advances in biodrug delivery systems and associated techniques. The book discusses components of successful formulation, delivery, and production of biodrugs, which include sophisticated plants and complex processes, a well-trained and knowledgeable staff, and proper quality control.

In addition, the authors examine: • ADME (Absorption, Metabolism, Distribution, and Elimination of biodrugs) • Directing and influencing the successful development of currently marketed best-selling biodrugs • Routes of administration • Mechanisms of biodrug absorption • Alternative possibilities for drug delivery routes • Formulations on the market from the perspective of industry personnel involved in biodrug development

Long Island University, Brooklyn, New York, USA

This volume discusses the broad and complicated realm of preclinical drug development. Topics discussed include pharmacokinetics, modeling and simulation, formulation and routes of administration, toxicity evaluations, the assessment of drug absorption and metabolism, and interspecies scaling. The authors also examine lead molecule selection and optimization via profiling and screening using in silico and in vitro toxicity evaluations. The book includes case studies on preclinical pharmacokinetic-pharmacodynamic modeling and simulation in drug development, a review of ICH preclinical guidelines, and experimental methods used to study membrane drug transport and metabolism.

Catalog no. H8472, September 2009, 376 pp.

ISBN: 978-1-4200-8472-6, $279.95 / £175.00 Also available as an eBook

Polymorphism in Pharmaceutical Solids

Selected Contents:

Second Edition

Overview of Biodrug Delivery System Issues in Biodrug Delivery System Pharmacokinetic Consideration of Biodrugs Specific Route of Delivery Parenteral Delivery Brain Delivery Ocular Delivery Nasal Delivery Buccal Delivery Pulmonary Delivery Transdermal Delivery Colon Delivery Oral Delivery Cellular Delivery Delivery Systems Targeting: PK Consideration Monoclonal Antibody Receptor-Mediated Endocytosis...

Edited by

Catalog no. H8668, December 2009, 488 pp.

ISBN: 978-1-4200-8668-3, $299.95 / £189.00 Also available as an eBook

Catalog no. H7321, July 2009, 656 pp.

ISBN: 978-1-4200-7321-8, $259.95 / £162.00 Also available as an eBook

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Harry G. Brittain Center for Pharmaceutical Physics, Milford, New Jersey, USA

Using clear and practical examples, this volume presents a comprehensive examination of polymorphic behavior in pharmaceutical development. The book is ideal for pharmaceutical development scientists and graduate students in pharmaceutical science. This second edition focuses on the pharmaceutical aspects of polymorphism and solvatomorphism, while systematically explaining their thermodynamic and structural origins. Topics in this edition include computational methodologies, high-throughput screening methods, pharmaceutical cocrystals, and thermally induced and solution-mediated phase transformations. The book also examines amorphous solids, the amorphous state, and crystallography preparation and characterization.

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Drug Development Pharmaceutical Preformulation and Formulation

New!

A Practical Guide from Candidate Drug Selection to Commercial Dosage Form, Second Edition

Basic Principles and Systems, Fifth Edition, Volume 1

Edited by

Mark Gibson Leicestershire, UK

Pharmaceutical Preformulation and Formulation: A Practical Guide from Candidate Drug Selection to Commercial Dosage Form reflects the mounting pressure on pharmaceutical companies to accelerate the new drug development and launch process, as well as the shift from developing small molecules to the growth of biopharmaceuticals. The book meets the need for advanced information for drug preformulation and formulation and addresses the current trends in the continually evolving pharmaceutical industry.

Topics include: • • • • • •

Candidate drug selection Drug discovery and development Preformulation predictions and drug selections Product design to commercial dosage form Biopharmaceutical support in formulation Development

The book is ideal for practitioners working in the pharmaceutical arena—including R&D scientists, technicians, and managers—as well as for undergraduate and postgraduate courses in industrial pharmacy and pharmaceutical technology.

Contents: Topical and Transdermal Drug Delivery Introduction and Perspective Aiding Candidate Selection: Introduction and Objectives Preformulation Predictions Biopharmaceutical Support in Candidate Drug Selection Early Product Development Preformulation as an Aid to Product Design in Early Development Biopharmaceutics Support to Formulation Development ...

Catalog no. H7317, June 2009, 560 pp.

ISBN: 978-1-4200-7317-1, $299.95 / £189.00 Also available as an eBook

Modern Pharmaceutics

Edited by

Alexander T. Florence and Juergen Siepmann With over 100 illustrations, Volume 1 addresses the core disciplines as well as the challenges and paradigms of pharmaceutics. Key topics include drug absorption, chemical kinetics, drug stability, pharmacokinetics, and the effect of route of administration and distribution on drug action. The book discusses in vivo imaging of dose forms, powder technology, excipient design and characterization, and preformulation. It also examines optimization techniques in pharmaceutical formulation and processing, disperse and surfactant systems, the solid state, tablet dosage forms, coating processes, hard and soft shell capsules, and parenteral products.

Catalog no. H6564, May 2009, 656 pp.

ISBN: 978-1-4200-6564-0, $139.95 / £125.00 Also available as an eBook

Modern Pharmaceutics Applications and Advances, Fifth Edition, Volume 2 Edited by

Alexander T. Florence and Juergen Siepmann Volume 2 addresses the applications and approaches in advanced drug delivery systems, including transdermal, pulmonary, and ocular routes. The text discusses the impact of the shift to personalized medicines in the fields of pharmaceutical biotechnology, pharmacogenomics, and nanotechnology. It investigates sustained- and controlled-release drug delivery systems, bioequivalence, cutaneous and transdermal delivery processes and systems, and the design and evaluation of ophthalmic pharmaceutical products. It examines delivery of drugs by the pulmonary route, pediatric pharmaceutics and formulation, and biotechnology-based pharmaceuticals. It discusses veterinary pharmaceutical dosage forms, target-oriented drug-delivery systems, and modern evaluation.

Catalog no. H6566, May 2009, 560 pp.

ISBN: 978-1-4200-6566-4, $139.95 / £125.00 Also available as an eBook

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Drug Delivery Obstructive Airway Diseases Role of Lipid Mediators Edited by

Abhijit Ray and Punit Kumar Srivastava Daiichi Sankyo Life Science Research Centre India (RCI), Gurgaon, Haryana

Incidences of inflammatory airway diseases are on the rise across the world and it is imperative that research be undertaken to discover new treatment options.

This volume discusses clinically successful and potential lipid targets that can make a difference in treating some of the most intractable disease states. Topics include the role of enzymes in lipid mediator synthesis; the biology of arachidonic acid, platelet-activating factor, and lysophosphatidic acid; and proresolution lipid mediators in inflammatory airway disease conditions. The book also examines the role of sphingosine and ceramide in inflammatory airway disease, and protein kinases activated by lipid mediators.

Catalog no. K12353, November 2011, 381 pp.

ISBN: 978-1-4398-5140-1, $167.95 / £107.00 Also available as an eBook

Pharmaceutical Dosage Forms and Drug Delivery Second Edition Ram I. Mahato University of Tennessee Health Science Center, Memphis, USA

Ajit S. Narang Bristol-Myers Squibb, Co., New Brunswick, New Jersey, USA

“Containing the right blend of mathematics, equations, diagrams, pictorials, and other pertinent information, this book provides a unified perspective that creates a greater overall understanding of basic science and cutting-edge technology.”

—Anticancer Research

In the second edition of Pharmaceutical Dosage Forms and Drug Delivery the authors integrate aspects of physical pharmacy, biopharmaceuticals, drug delivery, and biotechnology, emphasizing the increased attention that the recent spectacular advances in dosage form design and drug delivery, gene therapy, and nanotechnology have brought to the field.

Highlights of the Second Edition:

Drug Delivery Systems Third Edition Vasant V. Ranade Director of Chemical Research, Academic Pharmaceuticals Inc, Lake Bluff, Illinois, USA

John B. Cannon Targeted Drug Solutions, Grayslake, Illinois, USA

The third edition of this popular book contains the latest research and development on drug delivery systems. It also contains a new chapter on nanoscience and technology for drug delivery along with cutting-edge business intelligence and strategies throughout the text. Like previous editions, it continues to provide readers with a multitude of possible drug delivery systems that can be used to improve therapeutics as well as information on the technology involved and the regulatory approaches that make them useful. The authors introduce complex drug delivery technology in an easy-to-understand format with numerous practical examples.

Catalog no. K10307, April 2011, 608 pp.

ISBN: 978-1-4398-0618-0, $209.95 / £134.00 Also available as an eBook

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• Additional author Ajit S. Narang brings an industrial practitioner perspective with increased focus on pharmacy math and statistics, and powders and granules • Reorganized into three parts: Introduction, Physicochemical Principles, and Dosage Forms • Chapters on pharmaceutical calculations, compounding principles, and powders and granules provide a complete spectrum of application of pharmaceutical principles • Expansion of review questions and answers clarifies concepts for students and adds to their grasp of key concepts covered in the chapter • Coverage of complexation and protein binding aspects of physical pharmacy includes the basic concepts as well as recent progress in the field Although there are numerous books on the science of pharmaceutics and dosage form design, most cover different areas of the discipline and do not provide an integrated approach to the topics. This book not only provides a singular perspective of the overall field, but it supplies a unified source of information for students, instructors, and professionals.

Catalog no. K12224, October 2011, 512 pp.

ISBN: 978-1-4398-4918-7, $119.95 / £80.00 Also available as an eBook

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Drug Delivery Targeted Delivery of Small and Macromolecular Drugs

Water-Insoluble Drug Formulation

Edited by

Edited by

Ajit S. Narang

Rong Liu

Bristol-Myers Squibb, Co., New Brunswick, New Jersey, USA

Ram I. Mahato

University of Tennessee Health Science Center, Memphis, USA

Site-specific drug delivery and targeting has attracted much research interest from both academia and industry, but because of the wide array of challenges faced in the development of these systems, only a very few targeted therapies have made it to clinics.

Bringing together key research, this volume summarizes current progress with a focus on the novel ideas that are being explored to overcome these challenges. This forward-looking volume includes an indepth review of various aspects of these drug delivery approaches as well as a detailed discussion of a few case studies in each category.

Catalog no. 8772X, May 2010, 630 pp.

ISBN: 978-1-4200-8772-7, $109.95 / £69.99 Also available as an eBook

Oral Drug Absorption Prediction and Assessment Edited by

Jennifer B. Dressman Johann Wolfgang Goethe University, Frankfurt, Germany

Christos Reppas National and Kapodistrian University of Athens, Greece

Now in its second edition, this volume thoroughly examines the special equipment and methods used to test whether drugs are released adequately when administered orally. The book reviews major advances in pharmacokinetic modeling and profiling. It discusses methods for accurately establishing and validating in vitro/in vivo correlations for both MR and IR formulations, as well as alternative approaches for MR and IR formulations. This edition adds information about bioequivalence studies, biowaiving, formulation screening, and different approaches from U.S. industry and European industry perspectives. Case-based examples and a supplementary interactive CD-ROM are included.

Catalog no. H7733, March 2010, 450 pp.

ISBN: 978-1-4200-7733-9, $219.95 / £135.00 Also available as an eBook

Second Edition

AustarPharma, Edison, New Jersey, USA

Scientists have attributed more than 41 percent of the failures in new drug development to poor biopharmaceutical properties, particularly water insolubility. The most comprehensive resource on the topic, this volume brings together a distinguished team of experts to provide step-by-step guidance and scientific background on drug and water properties. Twenty-three chapters systematically describe solubility properties and their impact on formulation, from theory to industrial practice. With detailed discussion on how they contribute to solubilization and dissolution, the text also explores water-insoluble drugs, regulatory aspects, pharmacokinetic behaviors, and formulation strategies.

Catalog no. 9644, January 2008, 688 pp.

ISBN: 978-0-8493-9644-1, $359.95 / £229.00 Also available as an eBook

Oral Lipid-Based Formulations Enhancing the Bioavailability of Poorly Water-Soluble Drugs Edited by

David J. Hauss Bristol-Myers Squibb, Princeton, New Jersey, USA

Oral lipid-based formulations are attracting considerable attention due to their capacity to facilitate gastrointestinal absorption and reduce or eliminate food’s effect on the absorption of poorly water-soluble, lipophilic drugs. Despite the obvious utility of these formulations to address a persistent and growing problem of major significance, the pharmaceutical industry has been slow to apply and further develop this technology. This volume provides a comprehensive summary of the theoretical and practical aspects of oral lipid-based formulations for use in industry, providing insight into a developing technology expected to assume increasing prominence in years to come.

Catalog no. DK3780, June 2007, 368 pp.

ISBN: 978-0-8247-2945-5, $179.95 / £115.00 Also available as an eBook

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Drug Discovery New!

Applying Genomic and Proteomic Microarray Technology in Drug Discovery Second Edition

Ocular Drug Delivery Systems Barriers and Application of Nanoparticulate Systems Edited by

Deepak Thassu Actavis SSL R&D, Owings Mills, Maryland, USA

Robert S. Matson QuantiScientifics, LLC, California, USA

Microarrays play an increasingly significant role in drug discovery. The commercial landscape has changed dramatically over the past few years and researchers have made great advances with regard to construction and use. Now in its second edition, Applying Genomic and Proteomic Microarray Technology in Drug Discovery highlights, describes, and evaluates current scientific research using microarray technology in genomic and proteomic applications.

Updated and revised to reflect recent progress in the field, the second edition discusses: • Expanded omics-driven applications, including the areas of metabolomics and chemical biology • The commercialization of the microarray platform, with a historical perspective aimed at recognizing key technological developments • Solid-supports (substrates) and surface chemistries currently used in the creation of nucleic acid and protein microarrays

Gerald J. Chader University of Southern California Medical School, Doheny Eye Institute, Los Angeles, USA

Written for academic and industrial researchers in the field of ophthalmology, this book presents research on the development of currently marketed devices and recent trends in the topical delivery of drugs to the posterior of the eye. Examining drug delivery barriers and the application of nano-medicines to the eye, it includes chapters on ocular physiology and the application of nanoparticles-based delivery systems to enhance drug efficacy. Contributors include leading eye researchers, surgeons, and pharmacologists from academia, the National Eye Institute, and leading ophthalmic companies such as Pfizer, Allergan, and Novartis.

Catalog no. K12138, October 2012, 473 pp.

ISBN: 978-1-4398-4800-5, $169.95 / £108.00 Also available as an eBook

Pharmaceutical Dosage Forms

• Different approaches to producing microarrays that achieve spot equality with the same number of molecules properly oriented

Parenteral Medications, Third Edition

• The development of the gene expression microarray and representative applications

Edited by

• The development of protein microarray technology, including its history and key applications Unique to this edition is a new chapter on multiplex assays that examines the development and applications of arrays across diverse platforms. It discusses applications for qPCR, multiplex lateral flow, and multiplex bead assays. It also presents platform-to-platform comparisons.

Microarrays remain an invaluable tool for omics-based research not only in drug discovery, but in the life sciences, in clinical research, and for diagnostic applications worldwide. This volume presents the current state of the art on the utility of this technology to solve a host of important biological problems.

Catalog no. K12595, March 2013, 322 pp.

ISBN: 978-1-4398-5563-8, $149.95 / £95.00 Also available as an eBook

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Sandeep Nema and John D. Ludwig Pfizer R&D, Chesterfield, Missouri, USA

This three-volume set is an authoritative, comprehensive reference work on the formulation and manufacture of parenteral dosage forms, effectively balancing theoretical considerations with the practical aspects of their development. This third edition addresses the plethora of changes in the science and considerable advances in the technology associated with these products and routes of administration. It maintains the features that made the last edition so popular but includes several additional chapters, revisions to all other chapters, as well as high-quality illustrations.

Catalog no. H8653, August 2010, 500 pp.

ISBN: 978-1-4200-8653-9, $721.00 / £459.00

The individual volumes are available on pages 14 and 16

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Drug Discovery Drug Delivery Nanoparticles Formulation and Characterization

Nanoparticulate Drug Delivery Systems Edited by

Deepak Thassu

Edited by

PharmaNova Inc., Victor, New York, USA

Yashwant Pathak and Deepak Thassu

Michel Deleers

UCB Pharma, Chemin du Foriest, Braine L'Alleud, Belgium

Exploring fundamental concepts, this volume presents key aspects of nanoparticulate system development for various therapeutic applications and provides advanced methods used to file for regulatory approval. Featuring 100 high-quality images, the book begins by discussing recent developments in nanoparticulate drug delivery systems. Among other topics, it goes on to explore process analytical techniques (PAT) used in manufacturing nanoparticulate drug delivery systems (NPDDS), in vitro and in vivo evaluation of NPDDS, and applications of novel techniques used in formulation development and characterization, such as microscopic and nonmicroscopic techniques.

Yashwant Vishnupant Pathak

Catalog no. H7804, June 2009, 416 pp.

ISBN: 978-1-4200-7804-6, $239.95 / £150.00 Also available as an eBook

Textbook of Drug Design and Discovery Fourth Edition Edited by

Povl Krogsgaard-Larsen, Ulf Madsen, and Kristian Strømgaard The Faculty of Pharmaceutical Sciences, University of Copenhagen, Denmark

This fourth edition of a bestseller provides current and comprehensive information on all aspects of drug design and discovery. The first part of the book covers general aspects, methods, and principles and the second section covers specific targets and diseases.

Topics include biostructure- and ligand-based drug design, natural products, imaging, neurotransmitter transporters, opioid and cannabinoid receptors, hypnotics, neglected diseases, and antibiotics. Each chapter includes references for further study. Most chapters also supply background and history needed to provide context, as well as conclusions that summarize the important points.

Catalog no. 63227, October 2009, 476 pp.

ISBN: 978-1-4200-6322-6, $91.95 / £58.99 Also available as an eBook

University of South Florida, Tampa, USA

“ …includes a wealth of latest advances in the technology of nanoparticulates …”

—Professor Gregory Gregoriadis, The School of Pharmacy, University of London and Lipoxen Plc, London, UK (from the Foreword)

With the advent of analytical techniques and capabilities to measure particle sizes in nanometer ranges, there has been tremendous interest in the use of nanoparticles for more efficient methods of drug delivery. Nanoparticulate Drug Delivery Systems addresses the scientific methodologies, formulation, processing, applications, recent trends, and emerging technologies in the research of nanoparticulate drug delivery systems (NPDDS). It extensively covers applications of NPDDS— including lipid nanoparticles for dermal applications; nanocarriers for the treatment of restenosis; and for ocular, central nervous system, and gastrointestinal applications. It also explores its use as an adjuvant for vaccine development.

Supplying insight from international experts, this guide • Discusses formulation for poorly soluble drugs • Presents biological requirements for nanotherapeutic applications • Demonstrates the role of nanobiotechnology in the development of nanomedicine • Documents recent advances in nanoparticulate technology—including electrospining, formation of microcrystals, and production of liquid crystalline phases • Examines the technology of metallic nanoparticles

Selected Contents: Nanoparticulate Drug Delivery Systems: An Overview.

Nanosuspensions for Parenteral Delivery.

Nanoparticles Prepared Using Natural and Synthetic Polymers. Nanofiber-based Drug Delivery. Drug Nanocrystals: The Universal Formulation Approach for Poorly Soluble Drugs. Lipid Based Nanoparticulate Drug Delivery Systems. Nanoengineering of Drug Delivery Systems. ...

Catalog no. 9073, March 2007, 376 pp.

ISBN: 978-0-8493-9073-9, $179.95 / £115.00 Also available as an eBook

For more information and complete contents, visit www.crcpress.com

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Regulation Standards Forthcoming!

FDA Regulatory Affairs Third Edition

Sararaz K. Niazi Pharmaceutical Scientist Inc., Deerfield, Illinois, USA

Edited by

Douglas J. Pisano and David Mantus This third edition examines harmonization of the U.S. Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, research, manufacturing, and marketing. Focusing on the new drug approval process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements, this is a key resource for anyone involved in pharmaceutical regulation. Jargon-free and drawing information from a wide range of resources, the book demystifies the inner workings of the FDA and facilitates an understanding of how it operates with respect to compliance and product approval.

Catalog no. H100295, March 2014, 448 pp.

ISBN: 978-1-84184-919-5, $219.95 / £135.00 Also available as an eBook

Pharmaceutical Dosage Forms: Parenteral Medications Third Edition, Volume 3: Regulations, Validation and the Future Edited by

Sandeep Nema and John D. Ludwig Regulations, Validation and the Future is the third volume in the Pharmaceutical Dosage Forms: Parenteral Medications three-volume set. The book presents an in-depth discussion of regulatory requirements, quality assurance, risk assessment and mitigation, and extractables/leachables. It explores parenteral administrations devices, injection site pain assessment, parenteral product specifications, and stability testing. It also discusses and the future of parenteral product manufacturing and siRNA delivery systems. New chapters cover recent developments in the areas of visual inspection, quality by design (QbD), process analytical technology (PAT) and rapid microbiological methods (RMM), as well as validation of drug product manufacturing process.

Catalog no. H8647, December 2012, 318 pp.

ISBN: 978-1-4200-8647-8, $259.95 / £162.00 Also available as an eBook

The three-volume set is available on page 12.

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Handbook of Bioequivalence Testing

As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct efficient and successful bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence, and advances in the analytical technology used to detect drug and metabolite levels have made bioequivalence testing more difficult to conduct and summarize. The Handbook of Bioequivalence Testing offers a complete description of every aspect of bioequivalence testing.

Features: • Describes the current analytical methods used in bioequivalence testing, as well as their respective strengths and limitations • Discusses worldwide regulatory requirements for filing for approval of generic drugs • Covers GLP, GCP, and 21 CFR compliance requirements for qualifying studies for regulatory submission and facility certification • Includes actual examples of reports approved by regulatory authorities to illustrate various scientific, regulatory, and formatting aspects • Provides a list of vendors for the software used to analyze bioequivalence studies and recommendations • Explains how to apply for a waiver, how to secure regulatory approval of reports, and how to obtain regulatory certification of facilities conducting bioequivalence studies

Contents: Bioequivalence Testing Regulatory Aspect of Bioequivalence Testing Pharmacokinetic/Pharmacodynamic Modeling Waiver of BA/BE Studies Regulatory Review Process Statistical Evaluation of Bioequivalence Data Physicochemical Properties Drug Delivery Factors Bioanalytical Method Validation Good Clinical Practice Good Laboratory Practice for Nonclinical Lab Studies Computer and Software Validations Bioequivalence Reports Catalog no. DK0395, August 2007, 550 pp.

ISBN: 978-0-8493-0395-1, $239.95 / £150.00 Also available as an eBook

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Manufacturing & Engineering Dietary Supplement Good Manufacturing Practices Preparing for Compliance

Pharmaceutical Powder Compaction Technology Second Edition Edited by

Metin Çelik

William J. Mead Rowayton, Connecticut, USA

“This book may therefore become a useful tool to further the implementation of more ‘modern’ approaches towards product safety and quality and to actually help transitioning dietary supplements to become food also in real life and not only from a regulatory standpoint.”

—Elena Vittadini, International Journal of Food Science and Nutrition

“ … should be required reading for every quality control department in the supplement industry. The book dissects and digests the FDA’s lengthy regulations and preamble, making the minutiae of a very complicated rulemaking understandable so the requirements can actually be implemented. Bill Mead offers not only ‘what’ the rule requires but ‘how’ to comply, and ‘why’ each topic is critical to pass your next inspection.

Conscientious firms will want to read cover to cover before the FDA inspector knocks on the door.”

—Steve Mister, President & CEO, Council for Responsible Nutrition

Dietary Supplement GMP is a one-stop “how-to” road map to the final dietary supplement GMP regulations recently issued by the FDA covering the manufacture, packaging, and holding of dietary supplement products.

The recent regulations outline broad goals but intentionally avoid specifics to allow for future technological advances—leaving implementation to the discretion of each firm. Given this latitude and flexibility, this resource is an essential guide to workable and practical suggestions on ways the industry can best meet the goals. Based on broad experience with GMP compliance techniques worked out over the years in the food, drug, and medical device industries, the book is a must-have guide for all DS companies, especially the many smaller firms for whom this is new territory.

Pharmaceutical Technologies International, Pennsylvania, USA

Compaction of powder constituents—both active ingredient and excipients—is examined to ensure consistent and reproducible disintegration and dispersion profiles. Revised to reflect modern pharmaceutical compacting techniques, this second edition of Pharmaceutical Powder Compaction Technology guides pharmaceutical engineers, formulation scientists, and product development and quality assurance personnel through the compaction formulation process and application.

This unique reference covers: • The physical structure of pharmaceutical compacts • Bonding phenomena that occur during powder compaction • Compression mechanisms of pharmaceutical particles • Theories and basic principles of powder compaction

New topics include: • Compaction data analysis techniques • The migration of powder constituents into commercial manufacture • Instrumentation for compaction • Compaction functionality testing, which is likely to become a USP requirement • Design space for compaction • Metrics required for scalability in tablet compression • Interactive compaction and preformulation database for commonly used excipients

Contents:

• Provides practical guidance in easy-to-understand language to help navigate through the requirements for systems covering process and quality control • Includes suggestions and practical recommendations on how-to achieve full compliance • Explains the FDA’s role regarding inspection, enforcement, recall/seizure of products, and prosecution

Theory of Compaction: Intermolecular Bonding Forces: where materials and process come together.

Compaction Data Analysis Techniques: Viscoelastic Models. Application of Percolation Theory and Fractal Geometry to Tablet Compaction. Post Compaction Data Analysis Techniques. Instrumentation and Equipment in Compaction: Tablet Press Instrumentation in the Research and Development Environment. Advanced Compaction Research Equipment: Compaction Simulators. Compactability Functionality Test. ...

Catalog no. H7740, November 2011, 312 pp.

ISBN: 978-1-4200-7740-7, $159.95 / £100.00 Also available as an eBook

Catalog no. H8917, August 2011, 358 pp.

ISBN: 978-1-4200-8917-2, $279.95 / £175.00 Also available as an eBook

For more information and complete contents, visit www.crcpress.com

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Manufacturing & Engineering Pharmaceutical Water System Design, Operation, and Validation, Second Edition William V. Collentro Water is the most used raw material ingredient in the pharmaceutical and biotechnology industries. Drawing on the author’s extensive field experience with more than 400 pharmaceutical and related water purification systems, this volume provides numerous case studies to illuminate the best and worst of water system design and operation. Topics include passivation and electropolishing, rouging, ozone systems and accessories, USP purified water and water for injection, and individual component process and instrumentation diagram (P&IDs) with control interface. The book also examines documentation and specification requirements and systems installation, start-up, and commissioning.

Catalog no. H7782, December 2010, 478 pp.

ISBN: 978-1-4200-7782-7, $259.95 / £162.00 Also available as an eBook

Pharmaceutical Dosage Forms: Parenteral Medications Third Edition, Volume 1: Formulation and Packaging Edited by

Sandeep Nema and John D. Ludwig Formulation and Packaging is the first volume in the Pharmaceutical Dosage Forms: Parenteral Medications three-volume set. Volume 1 presents a historical perspective of injectable drug therapy. It discusses common routes of administration and biopharmaceutics of NCEs and NBEs. It examines the preformulation and formulation of small and large molecules, including ophthalmic dosage forms. The book also presents a range of parenteral primary packaging options— including glass and plastic containers and elastomeric closures—and discusses container-closure integrity. This edition includes new chapters on solubility and solubilization, formulation of depot delivery systems, and biophysical/biochemical characterization of proteins.

Catalog no. H8643, December 2012, 420 pp.

ISBN: 978-1-4200-8643-0, $259.95 / £162.00 Also available as an eBook

The three-volume set is available on page 12.

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Pharmaceutical Dosage Forms: Parenteral Medications Third Edition, Volume 2: Facility Design, Sterilization and Processing Edited by

Sandeep Nema and John D. Ludwig Facility Design, Sterilization and Processing is the second volume in the Pharmaceutical Dosage Forms: Parenteral Medications three-volume set. Volume 2 presents chapters on aseptic facility design, environmental monitoring, and cleanroom operations. It discusses pharmaceutical water systems and quality attributes of sterile dosage forms, including particulate matter, endotoxin, and sterility testing. The book contains a detailed discussion on the processing of parenteral drug products (SVPs and LVPs) as well as widely used sterilization technologies such as steam, gas/chemical, radiation, filtration, and dry heat. It also examines lyophilization.

Catalog no. H8645, December 2012, 406 pp.

ISBN: 978-1-4200-8645-4, $259.95 / £162.00 Also available as an eBook

The three-volume set is available on page 12.

Freeze Drying/ Lyophilization of Pharmaceutical and Biological Products Third Edition Edited by

Louis Rey and Joan C. May Freeze drying, or lyophilization, is a well-established technology used in the preservation of numerous pharmaceutical and biological products. This highly effective dehydration method involves the removal of water from frozen materials via the direct sublimation of ice. In recent years, this process has met with many changes, as have the regulations that impact lyophilization practices. This volume addresses these changes with revised chapters on emerging developments in lyophilization technology, research, and industry procedures. Providing both a scientific and industrial perspective, this comprehensive text is a valuable resource for all those who use freeze-drying technology.

Catalog no. H100116, June 2010, 578 pp.

ISBN: 978-1-4398-2575-4, $299.95 / £189.00 Also available as an eBook

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Manufacturing & Engineering Handbook of Pharmaceutical Granulation Technology Dilip M. Parikh

Pharmaceutical Packaging Handbook

Synthon Pharmaceuticals, Inc. Ellicott City, Maryland, USA

Edward Bauer Sewickly, Pennsylvania, USA

This volume presents pharmaceutical industry personnel and those in academia with critical updates on the recent advances in granulation technology and changes in FDA regulatory guidelines. Addressing precisely how these recent innovations and revisions affect unit operation of particle generation and granulation, this text assists readers in selecting the ideal technology for a company’s particular drug delivery system. This knowledge helps ensure that regulatory guidelines are followed and met in a cost-effective manner.

Pharmaceutical Packaging Handbook provides a complete overview of the role that packaging plays in the development and delivery of pharmaceuticals and medical devices. Supplying a thorough examination of the industry in size and scope, the book covers drug dosage forms, vaccines, biologically produced products, and medical foods.

Third Edition Edited by

Catalog no. H100055, November 2009, 676 pp.

ISBN: 978-1-4398-0789-7, $299.95 / £189.00 Also available as an eBook

Pharmaceutical Product Branding Strategies Simulating Patient Flow and Portfolio Dynamics Mark Paich and Jason Valant Colorado Springs, Colorado, USA

Corey Peck Lexidyne, LLC, Colorado Springs, Colorado, USA

Taking an operational approach to understanding driving forces, this volume details how marketers, forecasters, and brand planners can achieve optimal success by building internally consistent simulation models to project future behavior of patients, physicians, and R&D processes. Introducing readers to the complexities facing many pharmaceutical firms— specifically issues surrounding cross-functional coordination and knowledge integration—this guide provides a framework for dynamic modeling of interest to several pharmaceutical markets, including epidemiology, market definitions, compliance/persistency, and revenue generation in the context of patient flows or movements.

Features: • Discusses how packaging is designed and integrated into the product development cycle • Provides an overview of the regulatory environment procedures • Describes the materials used to package pharmaceuticals, including glass, metal, plastics, flexible films, rubber, and elastomers • Examines new hybrids used for packaging • Explores the processing techniques used with the materials to produce pharmaceutical containers • Discusses some of the strengths and weaknesses of the processes used for container fabrication • Explains retort, aseptic, gas, and radiation sterilization of products • Reviews labeling and design for pharmaceuticals, including how labels are produced, materials used, and production techniques Complete and straightforward, the book lists information in an easy-to-follow fashion, making it a complete standalone reference for anyone working in the pharmaceutical industry.

Catalog no. TX516, March 2009, 608 pp.

ISBN: 978-1-58716-151-3, $179.95 / £115.00 Also available as an eBook

Catalog no. H8770, March 2009, 312 pp.

ISBN: 978-1-4200-8770-3, $219.95 / £135.00 Also available as an eBook

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Manufacturing & Engineering Handbook of Pharmaceutical Manufacturing Formulations

Handbook of Pharmaceutical Manufacturing Formulations

Second Edition, Volume One, Compressed Solid Products

Volume Three, Liquid Products Sarfaraz K. Niazi Pharmaceutical Scientist Inc., Deerfield, Illinois, USA

Sarfaraz K. Niazi Compressed solids are the largest category of pharmaceutical formulations, comprising almost twothirds of all dosage forms. They present some of the greatest challenges to formulation scientists. The first volume in the Handbook of Pharmaceutical Manufacturing Formulations discusses formulations for more than 200 of the most widely used drugs for all types of release profiles, offering formulators a rare opportunity to start with an optimal composition.

Topics include bioequivalence testing rationale and principles, bioequivalence testing protocols, the GMP audit template, EU guidelines, and guidance on formulating compressed solids.

Catalog no. H8116, September 2009, 648 pp.

ISBN: 978-1-4200-8116-9, $319.95 / £200.00 Also available as an eBook

While liquid drugs do not share the compression problems of solid dosage forms, the filling problems of powder dosage forms, or the consistency problems of semisolid dosage forms, they do have their own set of considerations in the formulation and manufacturing stages.

Handbook of Pharmaceutical Manufacturing Formulations: Volume Three, Liquid Products presents practical details involved in complying with the current good manufacturing practice requirements in liquid manufacturing. It delineates things an FDA auditor will look for during a liquid manufacturing audit, issues that may arise during a US FDA inspection, and the protocols used for stability testing for new drugs and new dosage forms, drawn from the most current ICH guidelines.

Selected Contents:

Providing methodologies that can serve as a reference point for new formulations, this volume covers uncompressed solids, which include formulations of powders, capsules, powders ready for reconstitution, and other similar products. It explores regulatory and manufacturing guidelines, registration of pharmaceuticals for human use, process validation, bioequivalence regulatory review process and audit, and preapproval inspections. Additional topics in this second volume in the Handbook of Pharmaceutical Manufacturing Formulations include formulation factors in uncompressed dosage forms, dissolution testing of uncompressed solid dosage forms, approved excipients in uncompressed solid dosage forms, and uncompressed solids formulations.

Regulatory and Manufacturing Guidance Manufacturing Practice Considerations in Liquid Formulations Oral Solutions and Suspensions The FDA Drug Product Surveillance Program Changes to Approved NDAs and aNDAs Formulation Considerations of Liquid Products Container Closure Systems Stability Testing of New Drug Substances and Products Stability Testing: Photostability Testing of New Drug Substances and Products Stability Testing for New Dosage Forms Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products Evaluations of Stability Data Stability Data Package for Registration Applications in Climatic Zones III and IV EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use EDQM Certification Impurities: Guideline For Residual Solvents Electronic Records and Signatures [CFR 21 Part 11 Compliance] GMP Audit Template, EU Guidelines Bioequivalence Testing Protocols Dissolution Testing of Liquid Dosage Forms ...

Catalog no. H8118, September 2009, 392 pp.

ISBN: 978-1-4200-8118-3, $319.95 / £200.00 Also available as an eBook

Catalog no. H8123, September 2009, 400 pp.

ISBN: 978-1-4200-8123-7, $319.95 / £200.00 Also available as an eBook

Handbook of Pharmaceutical Manufacturing Formulations Second Edition, Volume Two, Uncompressed Solid Products Sarfaraz K. Niazi

18

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Manufacturing & Engineering Handbook of Pharmaceutical Manufacturing Formulations Volume Four, Semisolid Products Sarfaraz K. Niazi Pharmaceutical Scientist Inc., Deerfield, Illinois, USA

Drug manufacturers need a thorough understanding of the specific requirements that regulatory agencies impose on the formulation and efficacy determination of drugs contained in semisolid products. The Handbook of Pharmaceutical Manufacturing Formulations: Volume Four, Semisolid Products series covers the techniques and technologies involved in the preparation of products such as ointments, creams, gels, suppositories, and special topical dosage forms.

Contents:

Handbook of Pharmaceutical Manufacturing Formulations Volume Five: Over-the-Counter Products Sarfaraz K. Niazi While over-the-counter formulations have much in common with their prescription counterparts, they are presented in this series separately because of the development approach taken, labeling considerations required, and support available from suppliers of ingredients in designing these products. Coverage in this volume includes medicinal products for human and veterinary use, World Health Organization good manufacturing guidelines, solid oral dosage forms validation, and the current regulatory status of over-the-counter products.

Catalog no. H8128, September 2009, 480 pp.

ISBN: 978-1-4200-8128-2, $319.95 / £200.00 Also available as an eBook

Regulatory and Manufacturing Guidance Waiver of In Vivo Bioequivalence Study Quality Risk Management Pharmaceutical Quality System Pharmaceutical Development Pharmaceutical Development in Ctd Scale-Up and Post-Approval Changes for Nonsterile Semisolid Dosage Forms: Manufacturing Equipment Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Validation of Analytical Procedures Good Manufacturing Requirements for Active Pharmaceutical Ingredients FDA Active Pharmaceutical Ingredient Manufacturing Facility Inspection Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances Skin Irritation and Sensitization Testing of Generic Transdermal Drug Products Impurities In New Drug Substances Drug Products Impurities in New Drug Substances Formulation Factors in Semisolid Dosage Forms GMP Audit Template, EU Guidelines Dissolution Testing of Semisolid Dosage Forms Approved Excipients in Semisolid Dosage Forms Manufacturing Formulations

Handbook of Pharmaceutical Manufacturing Formulations

Catalog no. H8126, September 2009, 376 pp.

ISBN: 978-1-4200-8126-8, $319.95 / £200.00 Also available as an eBook

Catalog no. H8106, September 2009, 2094 pp.

ISBN: 978-1-4200-8106-0, $1865.00 / £1188.00 Also available as an eBook

Volume Six: Sterile Products Safaraz K. Niazi With the increasing number of potent products joining the long list of proven sterile products, the technology of manufacturing these products has evolved into a very sophisticated industry.

Highlights of this volume include formulations of sterile dosage forms, regulatory filing requirements of sterile preparations, NDA and aNDA filing requirements of sterile products, and formulations of pharmaceutical products based on their generic names.

Catalog no. H8130, September 2009, 464 pp.

ISBN: 978-1-4200-8130-5, $319.95 / £200.00 Also available as an eBook

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Handbook of Pharmaceutical Manufacturing Formulations Second Edition, 6-Volume Set

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Pharmacology & Toxicology Basic Pharmacokinetics Second Edition

Pharmacy

Mohsen A. Hedaya Associate Professor, Department of Pharmaceutics, Kuwait University

Knowledge of pharmacokinetics is critical to understanding the absorption, distribution, metabolism, and excretion of drugs. It is therefore vital to those engaged in the discovery, development, and preclinical and clinical evaluation of drugs, as well as practitioners involved in the clinical use of drugs. Using different approaches accessible to a wide variety of readers, Basic Pharmacokinetics: Second Edition demonstrates the quantitative pharmacokinetic relations and the interplay between pharmacokinetic parameters.

After a basic introduction to pharmacokinetics and its related fields, the book examines: • Mathematical operations commonly used in pharmacokinetics • Drug distribution and clearance and how they affect the rate of drug elimination after a single dose • Factors affecting drug absorption following extravascular drug administration, the rate and extent of drug absorption, and drug bioequivalence • The steady-state concept during constant rate intravenous infusion and during multiple drug administration • Renal drug elimination, drug metabolism, multicompartment models, nonlinear pharmacokinetics, and drug administration by intermittent intravenous infusion • Pharmacokinetic-pharmacodynamic modeling, noncompartmental pharmacokinetic data analysis, clearance concept from the physiological point of view, and physiological modeling • Clinical applications of pharmacokinetics, including therapeutic drug monitoring, drug pharmacokinetics in special populations, pharmacokinetic drug-drug interactions, pharmacogenomics, and applications of computers in pharmacokinetics Accompanying the book is a CD-ROM with selfinstructional tutorials and pharmacokinetic and pharmacokinetic-pharmacodynamic simulations, allowing visualization of concepts for enhanced comprehension. This learning tool received an award from the American Association of Colleges of Pharmacy for innovation in teaching, making it a valuable supplement to this essential text.

Catalog no. K12311, February 2012, 595 pp.

ISBN: 978-1-4398-5073-2, $89.95 / £57.99 Also available as an eBook

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What It Is and How It Works, Third Edition William N. Kelly William N. Kelly Consulting Inc., Oldsmar, Florida, USA

Now in its third edition, this volume continues to provide a comprehensive review of all aspects of pharmacy, from the various roles of pharmacists to particular health care-related events to career planning information. The book discusses distribution, prescribing, dispensing, and pricing, and an expanded chapter on informatics explores how pharmacy has evolved through information technology and automation. Additional chapters cover poison control, pharmacy schools, pharmacy organizations, the drug approval process, and career development. The book contains numerous tools to facilitate comprehension, including learning objectives, discussion questions and exercises to test assimilation, and websites and references to encourage further study.

Contents: What Is Pharmacy?

The Pharmacist Pharmacists and the Health Care System The Drug Use Process Pharmacy Supportive Personnel Pharmacy Informatics Pharmaceutical Care Ambulatory (Community) Pharmacy Health System Pharmacy Managed Care Pharmacy Home Health and Hospice Care Pharmacy Long-Term Care Pharmacy Government Pharmacy Drug Information and Poison Control Pharmacy Academia Pharmacy Organizations How Drugs Are Discovered, Tested, and Approved The Pharmaceutical and Biotechnology Industry Other Opportunities for Pharmacists Career Development Catalog no. K12446, July 2011, 488 pp.

ISBN: 978-1-4398-5305-4, $62.95 / £40.99 Also available as an eBook

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Pharmacology & Toxicology

Essentials of Law and Ethics for Pharmacy Technicians Third Edition Kenneth M. Strandberg North Dakota State University, Fargo, USA

Addressing the latest procedural, ethical, and technological developments in this rapidly changing field, this third edition of a bestseller includes a wealth of additional material, including an appendix on the legal standing of electronic transmission of prescriptions. It covers U.S. state and federal regulations pertaining to the administration of new medications, including birth control and the morning-after pill, as well as current regulations on over-the-counter label claims. An essential resource for students as well as practicing technicians, this reference brings together the information that pharmacy technicians need to practice in a manner that is both legal and ethical.

Selected Contents: The Legal System in the United States Legislation, Regulation, and Interpretation Criminal Versus Civil Law History And Development of Current Law Into the Twentieth Century Food, Drug, and Cosmetic Act Of 1938 Adulteration Misbranding Drug Samples Investigational New Drugs New Drug Applications The Drug Price Competition and Patent-Term Restoration Act of 1984 The Orphan Drug Act of 1983 Prescribing Requirements and Restrictions Dispensing Requirements and Restrictions Drug Pedigrees Federal Controlled Substance Act of 1970 Other Pertinent Federal Legislation Ethics Theory and Application The Development of Pharmaceutical Ethical Considerations Code Of Ethics Background And Progression Pharmacy — A Respected Tradition Pharmacy-Related Relationships Communicating Professionally in an Information Age Patient’s Rights Modern Controversial Issues

Adverse Drug Interactions: A Handbook for Prescribers Lakshman Karalliedde, Simon Clarke, Ursula Collignon, and Janaka Karalliedde This portable book is an essential guide for those prescribing two or more drugs for simultaneous use.

Providing critical information on potential adverse effects, the book is organized by drug class in a convenient, user-friendly format. Interactions that are likely to give rise to life-threatening conditions and which must therefore be completely avoided are clearly highlighted. The book also details less threatening, but nonetheless important interactions necessitating practical measures such as frequent monitoring and advice to patients. The range of coverage includes not only prescription drugs but also over-the-counter medications, herbal remedies, and dietary supplements.

Contents: Cardiovascular Drugs Drugs Acting on the Nervous System Anticancer and Immunomodulating Drugs Anticoagulants Anitdiabetic Drugs Other Endocrine Drugs Analgesics Muscoskeletal Drugs Anaesthetic Drugs Drugs to Treat Infections Drugs Acting on the Gastrointestinal Tract Respiratory Drugs Metabolic Drugs Drugs Used in Obstetrics and Gynaecology Urological Drugs Drugs of Abuse Catalog no. K18788, January 2010, 849 pp.

Soft Cover, ISBN: 978-0-340-92769-4 $41.95 / £25.99

Catalog no. K12451, July 2011, 186 pp.

ISBN: 978-1-4398-5315-3, $55.95 / £35.99 Also available as an eBook

For more information and complete contents, visit www.crcpress.com

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Pharmacology & Toxicology Textbook of Receptor Pharmacology

A Guide to Practical Toxicology Evaluation, Prediction, and Risk, Second Edition

Third Edition Edited by

John C. Foreman and Alasdair J. Gibb

Adam Woolley

University College London, UK

ForthTox Limited, West Lothian, UK

Torben Johansen

An invaluable guide to evaluating toxicity and related data, this practical text surveys the basic principles of toxicology, examines toxicity testing and interpretation, and discusses the concepts of hazard prediction and risk assessment and management. The book describes how to evaluate various groups of chemicals, including pharmaceuticals, cosmetics, and agrochemicals. Topics include toxicity determination, normality and naturality, interpretation of data, prediction, and regulation. It also discusses safety pharmacology, evaluation of different chemical classes, and the future of toxicity testing.

University of Southern Denmark, Odense

Contents Introduction To Toxicology: The Necessity of Measurement Normality: Definition and Maintenance Determination of Toxicity: Basic Principles Determination of Toxicity in Vitro Safety Pharmacology Determination: General and Reproductive Toxicology Determination: Genotoxicity and Carcinogenicity Determination: Irritation and Sensitization Determination: Environmental Toxicology and Epidemiology Interpretation Prediction of Hazard Background to Risk Due to Toxicity Risk Assessment in Practice and Setting Exposure Limits Risk Assessment and Management in the Workplace Risk Assessment: Carcinogenicity; The Environment; Evolution and Overview of Risk Assessment Evaluation of Specific Groups of Chemicals The Future of Toxicity Testing Catalog no. 43145, September 2008, 472 pp.

Soft Cover, ISBN: 978-1-4200-4314-3 $79.95 / £50.00 Also available as an eBook

“This book is ideal for budding pharmacologists and cell physiologists, both at the undergraduate and postgraduate level, who have an interest in receptor structure and function … would also be of value to students and academics of pharmacy, physiology, medicinal chemistry, and related disciplines.”

—Chromatographia

For the past four decades, University College London has offered a renowned course on receptor pharmacology. Originating from this course, the perennially bestselling Textbook of Receptor Pharmacology has presented in-depth coverage of this rapidly expanding area of research. This third edition continues to combine current understanding of classical quantitative pharmacology and drug-receptor interactions with the basics of receptor structure and signal transduction mechanisms, providing an integrated analysis of the mechanisms of drug action at membrane receptors.

The hallmark of this popular text is the uniting of four major approaches to the study of receptors: • Molecular investigation of receptor structure • Quantitative functional studies of agonists and antagonists • Ligand binding • Signal transduction at the cell membrane Maintaining the second edition’s focus on cell membrane receptors and the immediate signal transduction events at the membrane, this edition includes updated chapters on receptor structure and signal transduction by G-proteins and tyrosine kinases as well as enhancements to the quantitative treatment of drug-receptor interactions. Several chapters contain problems and worked-out solutions, giving students the ability to test their comprehension of the material. Hundreds of diagrams and figures further enhance the text.

A time-saving resource and comprehensive learning tool, Textbook of Receptor Pharmacology, Third Edition carries on the tradition of providing in-depth, up-to-date coverage of this critical area that is both fundamental to the science of pharmacology and on the cutting edge of new drug development.

Catalog no. 52543, September 2010, 303 pp.

ISBN: 978-1-4200-5254-1, $119.95 / £77.99 Also available as an eBook

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Making and Using Antibodies A Practical Handbook, Second Edition Edited by

Gary C. Howard The Gladstone Institutes, San Francisco, California, USA

Matthew R. Kaser Bell & Associates, San Francisco, California, USA

Understand the Role of Antibodies in a Host of Biomedical Applications Antibodies protect us from a wide range of infectious diseases and cancers and have become an indispensable tool in science—both for conventional immune response research as well as other areas related to protein identification analysis. This second edition of Making and Using Antibodies: A Practical Handbook: • Provides clear descriptions of basic methods for making and using antibodies • Includes new chapters on western blotting, humanized antibodies, aptamers, and more • Describes basic laboratory techniques in detail, accompanied by practical examples • Features introductory material for each chapter • Examines potential problems and offers troubleshooting tips Catalog no. K13167, July 2013, 458 pp., ISBN: 978-1-4398-6908-6, $149.95 / £95.00

6000 Broken Sound Parkway, NW, Suite 300 Boca Raton, FL 33487, USA

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For a complete list of Pharmaceutical references, please visit www.crcpress.com

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